Virtual Psychological Intervention for ACL Injury

Overseen By Brittaney Pratt

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Henry Ford Health System

Must not be taking: Corticosteroids, Immunosuppressants

Disqualifiers: Revision ACL surgery, Infections, Autoimmune diseases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 24 months

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of this parallel arm prospective randomized control trial study is to compare outcomes in Anterior Cruciate Ligament Reconstruction (ACLR) Surgery patients after exposure to a virtual psychological intervention (VPI) versus standard care. The main question the investigators are asking is if virtual administration of psychological CBT modules will be an accessible and convenient vehicle to improve ACLR outcomes. Participants will be placed either into a treatment group receiving virtual modules of cognitive behavioral therapy in addition to standard of care ACLR surgery or the control group receiving only the standard of care ACLR surgery. The investigators hypothesize that ACLR patients in the VPI cohort will have improved return to sport and post operative outcomes compared to controls.

Do I need to stop my current medications for this trial?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you have taken corticosteroids or immunosuppressive agents within 30 days before surgery.

Is virtual psychological intervention generally safe for humans?

Research on online psychological interventions, including those for PTSD and other mental health conditions, suggests they are generally safe for humans. Studies have shown that these interventions can be safely implemented and may provide an alternative to face-to-face treatment. ^{1 2 3 4 5}

How is the Virtual Psychological Intervention for ACL Injury different from other treatments?

The Virtual Psychological Intervention for ACL Injury is unique because it uses internet-based cognitive behavioral therapy (iCBT), which allows patients to receive psychological support remotely through a web platform. This approach is scalable and can reach individuals who might not have access to traditional in-person therapy, making it a flexible and accessible option for psychological support. ^{4 6 7 8 9}

What data supports the effectiveness of the treatment Virtual Psychological Intervention for ACL Injury?

Research shows that internet-based cognitive behavioral therapy (iCBT) and videoconferencing psychotherapy (VCP) are effective for treating mental health issues like depression, anxiety, and PTSD. These therapies are convenient and have similar outcomes to traditional face-to-face therapy, suggesting they could be beneficial for psychological support after ACL injury as well. ^{6 7 10 11 12}

Who Is on the Research Team?

Thomas Sean Lynch, MD

Principal Investigator

Henry Ford Health System

Are You a Good Fit for This Trial?

This trial is for individuals over the age of 12 who have an ACL injury and are undergoing their first ACL reconstruction with a Henry Ford Sports Orthopedic Surgeon. It's not suitable for those who don't meet these specific conditions.

Inclusion Criteria

I am over 12 and having ACL surgery with a Henry Ford Sports Orthopedic Surgeon.

This is my first ACL reconstruction on the injured knee.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo ACLR surgery and receive either standard post-operative rehabilitation or additional virtual psychological intervention

24 months

Virtual sessions for Group A, standard care visits for both groups

Follow-up

Participants are monitored for return to sport and other outcomes at 3, 6, 12, and 24 months

24 months

Follow-up assessments at 3, 6, 12, and 24 months

What Are the Treatments Tested in This Trial?

Interventions

• Virtual Psychological Intervention

Trial Overview The study is testing if virtual cognitive behavioral therapy (CBT) can improve recovery outcomes after ACL surgery, compared to standard care alone. Participants will be randomly assigned to either receive virtual CBT modules plus standard care or just the standard post-surgery care.

How Is the Trial Designed?

Group I: Standard Post-Operative Rehabilitation Active Control 1 Intervention

No intervention, patients will receive the standard level of care.

Group II: Virtual Psychological Intervention Active Control 1 Intervention

An asynchronous course of pre- and post-operative CBT modules (VPI) will be delivered to patients in Group A as an adjuvant treatment to standard-of-care rehabilitation.

Who Is Running the Clinical Trial?

Henry Ford Health System

Lead Sponsor

Trials

334

Recruited

2,197,000+

Published Research Related to This Trial

A study involving 225 patients using therapist-assisted internet-delivered cognitive behaviour therapy (T-ICBT) for depression and anxiety revealed that 64% of participants highlighted the strengths of the course, such as downloadable content and the sharing of patient experiences.

Patient feedback indicated areas for improvement, including a desire for more diverse patient stories and better alignment of therapist availability with patient needs, which can enhance the effectiveness and personalization of T-ICBT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient Perspectives on Strengths and Challenges of Therapist-Assisted Internet-Delivered Cognitive Behaviour Therapy: Using the Patient Voice to Improve Care. Hadjistavropoulos, HD., Faller, YN., Klatt, A., et al.[2020]

Videoconferencing psychotherapy (VCP) is a feasible alternative to traditional face-to-face therapy, showing similar clinical outcomes and high user satisfaction across diverse populations and therapeutic formats, based on a review of 65 studies.

Despite the growing number of publications on VCP, further large-scale clinical trials are needed to better evaluate its efficacy and effectiveness in treating mental health issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Videoconferencing psychotherapy: a systematic review. Backhaus, A., Agha, Z., Maglione, ML., et al.[2022]

The study analyzed 18 months of user data from the 'Just a Thought' iCBT program in New Zealand, revealing that while there were significant reductions in mental distress, overall course adherence was low, particularly among younger users and certain ethnic groups.

Users who completed more lessons and had higher initial levels of distress were more likely to experience clinically meaningful improvements, suggesting that strategies to enhance adherence, such as healthcare worker prescriptions, could increase the effectiveness of iCBT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Internet-based cognitive behavioural therapy in the real world: Naturalistic use and effectiveness of an evidence-based platform in New Zealand. Guiney, H., Mahoney, A., Elders, A., et al.[2023]

A study involving 207 veterans with PTSD found that cognitive processing therapy (CPT) delivered via videoconference (VC) was as effective as in-person (IP) therapy in reducing PTSD symptoms at a six-month follow-up, indicating that VC can be a viable treatment option.

While VC showed non-inferiority to IP for long-term symptom improvement, it was less effective immediately after treatment, suggesting that in-person therapy may provide quicker benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Videoconferencing psychotherapy for veterans with PTSD: Results from a randomized controlled non-inferiority trial. Liu, L., Thorp, SR., Moreno, L., et al.[2021]

Videoconference-delivered psychotherapy (VCP) is effective for children and adolescents with mental disorders, showing large reductions in symptoms compared to waitlist controls, with an effect size of -1.26.

VCP is equally effective as in-person therapy for reducing symptoms and functional impairments in children, although it was particularly effective for internalizing disorders, indicating its potential as a viable treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of videoconference-delivered psychotherapy for children, adolescents, and their parents: A meta-analysis of randomized controlled trials. von Wirth, E., Willems, S., Döpfner, M., et al.[2023]

Computerized and internet-based interventions (IBIs) for treating traumatic stress-related conditions, such as anxiety and depression, show effectiveness comparable to traditional psychosocial treatments, based on a comprehensive review of existing literature.

While IBIs for anxiety and depression yield strong results, those aimed at alcohol and smoking cessation have lower effectiveness, suggesting that the common cognitive behavioral components may contribute to symptom reduction, though the exact mechanisms remain unclear.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Internet-based interventions for traumatic stress-related mental health problems: a review and suggestion for future research. Amstadter, AB., Broman-Fulks, J., Zinzow, H., et al.[2022]

A four-year randomized controlled trial is underway to compare the effectiveness of in-person Prolonged Exposure therapy for PTSD with therapy delivered via home-based telehealth technology, addressing concerns about safety and treatment efficacy.

Home-based telehealth may improve access to evidence-based psychotherapies for veterans with PTSD, who often face barriers to receiving traditional in-person treatment, potentially leading to better mental health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home-based telehealth to deliver evidence-based psychotherapy in veterans with PTSD. Strachan, M., Gros, DF., Yuen, E., et al.[2022]

Web-based self-directed psychological interventions have been found to significantly reduce symptoms of depression (g = 0.30), anxiety (g = 0.19), and distress (g = 0.36) in adults with chronic health conditions, based on a review of 70 studies.

While these interventions show general efficacy, their effectiveness varies across specific chronic health conditions, indicating a need for more targeted research to determine their impact on individual health issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Online psychological interventions to reduce symptoms of depression, anxiety, and general distress in those with chronic health conditions: a systematic review and meta-analysis of randomized controlled trials. White, V., Linardon, J., Stone, JE., et al.[2022]

The pilot study involving 34 veterans with PTSD demonstrated that the online writing intervention (WIRED) was feasible and safe to implement alongside traditional mental health treatment, showing promise as an adjunct therapy.

Preliminary results indicated that the TAU + WIRED intervention effectively reduced symptoms of hyperarousal in veterans, suggesting it could be a valuable alternative to face-to-face therapy for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Internet-based writing intervention for PTSD in veterans: A feasibility and pilot effectiveness trial. Krupnick, JL., Green, BL., Amdur, R., et al.[2018]

The ongoing randomized controlled trials are comparing the effectiveness of in-person psychotherapy versus video teleconferencing psychotherapy for military veterans with posttraumatic stress disorder (PTSD).

The study aims to evaluate not only the efficacy of these two delivery methods but also to share insights on training, technology use, and the challenges faced during the trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lessons learned from studies of psychotherapy for posttraumatic stress disorder via video teleconferencing. Thorp, SR., Fidler, J., Moreno, L., et al.[2012]

A study involving 12 participants provided positive feedback on digital materials designed for a remote intervention aimed at reducing intrusive memories of trauma, indicating strong potential for effective delivery.

Participants suggested specific improvements to enhance clarity and identified challenges related to the lack of real-time communication, which will be addressed in future pilot testing of the intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Digitalizing a Brief Intervention to Reduce Intrusive Memories of Psychological Trauma: Qualitative Interview Study. Gamble, B., Depa, K., Holmes, EA., et al.[2021]

Internet-based cognitive-behavioral therapy (CBT) is an effective self-help program that allows patients to receive psychological support via the Internet, making therapy more accessible, especially for those unable to attend traditional sessions.

This form of therapy has shown particular effectiveness in treating conditions like panic disorder, social phobia, and depression, indicating its potential to reach and help a wider range of individuals in need of mental health support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Internet-based cognitive-behavioral therapy in the treatment of psychiatric disorders]. Holmberg, N., Kähkönen, S.[2022]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Patient Perspectives on Strengths and Challenges of Therapist-Assisted Internet-Delivered Cognitive Behaviour Therapy: Using the Patient Voice to Improve Care. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Videoconferencing psychotherapy: a systematic review. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Internet-based cognitive behavioural therapy in the real world: Naturalistic use and effectiveness of an evidence-based platform in New Zealand. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Videoconferencing psychotherapy for veterans with PTSD: Results from a randomized controlled non-inferiority trial. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Effectiveness of videoconference-delivered psychotherapy for children, adolescents, and their parents: A meta-analysis of randomized controlled trials. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Internet-based interventions for traumatic stress-related mental health problems: a review and suggestion for future research. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Home-based telehealth to deliver evidence-based psychotherapy in veterans with PTSD. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Online psychological interventions to reduce symptoms of depression, anxiety, and general distress in those with chronic health conditions: a systematic review and meta-analysis of randomized controlled trials. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

An Internet-based writing intervention for PTSD in veterans: A feasibility and pilot effectiveness trial. [2018]

10. United States pubmed.ncbi.nlm.nih.gov

Lessons learned from studies of psychotherapy for posttraumatic stress disorder via video teleconferencing. [2012]

11. Canada pubmed.ncbi.nlm.nih.gov

Digitalizing a Brief Intervention to Reduce Intrusive Memories of Psychological Trauma: Qualitative Interview Study. [2021]

12. Finland pubmed.ncbi.nlm.nih.gov

[Internet-based cognitive-behavioral therapy in the treatment of psychiatric disorders]. [2022]